Phaseolamin compositions and methods for using the same

ABSTRACT

The present invention is for compositions containing phaseolamin and a mineral, such as chromium or vanadium or both, where the mineral is bound by a glycoprotein matrix. The present invention is also directed to methods for controlling carbohydrate cravings, inducing weight loss, reducing insulin requirements in a diabetic, and inhibiting the absorption of dietary starch by administering a composition of the invention.

BACKGROUND OF THE INVENTION

[0001] Glycoproteins (glycosylated proteins) are organic compoundscomposed of both a protein and a carbohydrate joined together by acovalent linkage. Glycosylated proteins are present on extracellularmatrices and cellular surfaces of many cells. Oligosaccharides consistof a few covalently linked monosaccharide units, such as glucose andribulose. The oligosaccharide moieties of glycoproteins are implicatedin a wide range of cell-cell and cell-matrix recognition events.

[0002] The addition of carbohydrates such as oligosaccharides, on aprotein involves a complex series of reactions that are catalyzed bymembrane-bound glycosyltransferases and glycosidases.Glycosyltransferases are enzymes that transfer sugar groups to anacceptor, such as another sugar or a protein. Glycosidases are enzymesthat remove sugar groups. The types and amounts of sugars that areattached to a given protein depend on the cell type in which theglycoprotein is expressed. In addition, the types of linkage used tojoin various sugar groups together also confound the complexity ofglycosylation.

[0003] The biological activities of many glycoproteins are notdetectably different if the carbohydrates are removed. However,glycosylation of proteins may have several effects. Carbohydrates oftenlengthen the biological life of a protein by decreasing the protein'srate of clearance from the blood. In addition, carbohydrates may help aprotein to fold properly, stabilize a protein, or affect physicalproperties such as solubility or viscosity of a protein.

[0004] Phaseolamin is a glycoprotein found mainly in white and redkidney beans and is known to be an amylase inhibitor. Amylase is anenzyme responsible for the breakdown or digestion of starch. Starch isthe main source of carbohydrates in the human diet. The digestion ofstarch begins in the mouth. Alpha-amylase present in saliva randomlyhydrolyzes the α(1→4) glucosidic bonds of starch except for theoutermost bonds and those next to branches.

[0005] By the time the thoroughly chewed food reaches the stomach, theaverage chain length of starch is reduced from several thousand to lessthan eight glucose units. The acid level in the stomach inactivates thealpha-amylase. Further digestion of starch continues in the smallintestine by pancreatic alpha-amylase, which is similar to that ofsalivary alpha-amylase.

[0006] Decreasing the absorption of carbohydrates by inhibiting thedigestion of starch is a very promising strategy in the fields of, forexample weight loss and diabetes mellitus. From a dietary standpoint, itis important to target the breakdown of starch since starch is arelatively nonessential nutrient, which provides calories with fairlylittle benefit. Furthermore, as starch is broken down into simple sugarsand absorbed from the digestive tract, the pancreas is triggered toproduce insulin. Increase in insulin production causes an individual tofeel hunger.

[0007] Several clinical studies, however, demonstrated that commerciallyavailable crude bean amylase inhibitors, when given with a starch meal,failed to influence fecal calorie excretion, postprandial concentrationsof plasma glucose or breath hydrogen, and metabolism of ¹³C-labeledstarch. In addition, administration of amylase inhibitors has beenassociated with side effects, such as abdominal discomfort and diarrhea.

[0008] It is estimated that approximately 40% of the United Statespopulation suffer from obesity (Glazer, G. (2001) Arch. Intern. Med.161:1814-1824). Obesity has been associated with many illnesses, such ascardiovascular disease, respiratory illness including asthma, sleepapnea, pick-wichian syndrome, diabetes mellitus and pulmonaryhypertension. In addition, adenocarcinoma of the esophagus and gastriccardia (Lagergren, J. et al. (1999) Ann. Intern. Med. 130:883-890),hepatic necrosis, and cirrhosis (Ratziu, V. et al. (2000)Gastroenterology 118:1117-1123) have recently shown strong correlationwith obesity.

[0009] Approximately 90% of all obese individuals who try to lose weightfail. One reason is that the majority of obese individuals are reluctantto give up eating certain foods, including starches (i.e., pasta, bread,and potatoes). Therefore, a dietary supplement that effectively inhibitsthe digestion and breakdown of starch, without harmful side effects,will be beneficial in helping these individuals achieve weight loss.

[0010] In addition to assisting weight loss, inhibiting the digestion orbreakdown of starch may also be beneficial in illnesses such as, forexample, diabetes mellitus. Currently, between 120 and 140 millionpeople worldwide suffer from diabetes mellitus and by the year 2025, itis estimated that this number may double. Much of the increase inindividuals suffering from diabetes mellitus will occur in developingcountries due to population aging, unhealthy diets, obesity, and asedentary lifestyle.

[0011] Diabetes mellitus is a chronic disease characterized by adeficiency in the production of insulin by the pancreas, or byineffectiveness of the insulin produced to utilize glucose. Thisimpairment in glucose utilization results in increased concentrations ofglucose in the blood, which leads to damage of many of the body'ssystems, such as the blood vessels and nerves. Therefore, preventing thebreakdown of starch into smaller sugar units, such as glucose, will bebeneficial in the prevention and/or treatment of diabetes mellitus.

[0012] Numerous articles have been published concerning amylaseinhibition. Some of these articles have indicated thatamylase-inhibitors worked well in vitro, but failed to be effective inhumans. Some of the proffered reasons were 1) insufficient activity; 2)destruction in the gastrointestinal tract; 3) suboptimal pH conditions;and 4) differing gastric emptying rates of starch and inhibitor.

[0013] Previous attempts to block starch absorption have failed for manyreasons including the instability of the starch-blockers employed. Thus,there remains a need for a stable, inhibitor of starch digestion withenhanced bioactivity and decreased side effects.

SUMMARY OF THE INVENTION

[0014] The present invention is for a composition comprising phaseolaminand a mineral, where the mineral is bound by a glycoprotein matrix. Inone embodiment, the mineral is chromium or vanadium or both. In anotherembodiment, the composition also comprises microorganisms. In yetanother embodiment, the microorganisms produce the glycoprotein matrix.

[0015] In a preferred embodiment, the microorganisms include yeast, suchas Saccharomyces cervisiae. In another embodiment, the microorganismsinclude bacteria such as Lactobacillus, including Lactobacillusacidophillus or Bacterium bifidus. In yet another embodiment, themicroorganisms include both yeast and bacteria.

[0016] In one aspect of the invention, the composition also comprisesstabilizers and/or additives. In another aspect, the composition isadded to a baking mix such as pancake, waffle, bread, biscuit and cookiemix.

[0017] The present invention is also directed to a method for inhibitingabsorption of dietary starch in a host. The method comprisesadministering to a host, an effective amount of a composition comprisingphaseolamin and a mineral, such as, for example, chromium or vanadium orboth. The mineral is bound by a glycoprotein matrix.

[0018] In one aspect of the invention a method for inducing weight lossin a host in need thereof is provided. The method comprisesadministering an effective amount of a composition comprisingphaseolamin and a mineral, such as, for example, chromium or vanadium.The mineral is bound by a glycoprotein matrix.

[0019] In another aspect of the invention, a method for controllingcarbohydrate cravings in a host in need thereof is provided. The methodcomprising administering an effective amount of a composition comprisingphaseolamin and a mineral, such as, for example, chromium or vanadium orboth. The mineral is bound by a glycoprotein matrix.

[0020] In a final embodiment, a method for decreasing insulinrequirements in a diabetic host is provided. The method comprisesadministering to the host, an effective amount of a compositioncomprising phaseolamin and a mineral, such as, for example, chromium orvanadium or both. The mineral is bound by a glycoprotein matrix.

BRIEF DESCRIPTION OF THE FIGURE

[0021]FIG. 1.: Efficacy of Phaseolamin

[0022] The efficacy of phaseolamin was compared in two groups, onereceiving a starch-meal(placebo), the other receiving a starch meal plusphaseolamin. The plasma glucose levels of the two groups were compared.The group receiving the phaseolamin had markedly lower plasma glucoselevels during the time after the starch meal was consumed.

DETAILED DESCRIPTION OF THE INVENTION

[0023] In accordance with the present invention, a composition isprovided which includes phaseolamin and a mineral, wherein the mineralis bound to a glycoprotein matrix. The composition of the inventionprovides improved stability and bioactivity characteristics of themineral, in conjunction with the starch inhibition properties ofphaseolamin.

[0024] The glycoprotein matrix of the present invention is bound to atleast one mineral. The glycoprotein matrix and mineral can be associatedwith each other physically and/or chemically, such as by chemicalreaction, and/or secondary chemical bonding, e.g., Van der Waals forces,etc. Not being bound by theory, it is believed that the glycoproteinmatrix may be bound to the mineral by weak covalent bonds.

[0025] The composition can contain essentially any percentage of mineraland phaseolamin as desired. For example, the percentage of mineral canvary between 0.1 and 99% by weight of the composition depending upon themineral and the desired result in the host. The percentage ofphaseolamin can vary between 0.1 and 99% by weight of the compositiondepending upon desired result in the host.

[0026] Glycoprotein Matrix

[0027] The glycoprotein matrix is the glycoprotein to which the mineralis bound. Glycoprotein is a composite material made of a carbohydrategroup and a simple protein. A glycoprotein matrix is a molecular networkcomprised of a plurality of glycoprotein molecules bound together.

[0028] The carbohydrate in the glycoprotein can be any suitablecarbohydrate, such as a monosaccharide, disaccharide, oligosaccharide,or polysaccharide. Oligosaccharide is preferred. The protein of theglycoprotein can be any suitable polypeptide. The ratio of carbohydrateto protein in the glycoprotein matrix can vary, for example, from 99:1to 1:99 by weight. A ratio of approximately 1:1 is preferred.

[0029] The ratio of glycoprotein matrix to mineral can also vary. It ispreferred that the ratio of glycoprotein matrix to mineral will be suchthat all or nearly all of the mineral in the composition is bound byglycoprotein matrix. To ensure that essentially all of the mineral isbound, higher ratios of glycoprotein matrix to mineral can be used.

[0030] The invention also contemplates a composition where there may beinsufficient glycoprotein to bind the entire amount of the mineral. Insuch cases, the ratio of glycoprotein matrix to mineral can be less.

[0031] In a preferred embodiment, the source of the glycoprotein matrixis a microorganism and, therefore, a preferred composition of theinvention will include microorganisms. At the end of the manufacturingprocess of the composition, these microorganisms are usually inactive.

[0032] The glycoprotein matrix can be bound to the mineral by allowingthe microorganism to ferment, in the presence of the mineral. As usedherein, fermentation is the process by which microorganisms metabolizeraw materials, such as amino acids and carbohydrate, to produceglycoprotein.

[0033] The microorganisms produce glycoprotein both intracellularly andextracellularly The intracellular glycoprotein will mainly be located inthe cytoplasm of the microorganism or become part of the microorganism'sphysical structure. The glycoprotein from the microorganism that formsthe glycoprotein matrix is mainly extracellular and, therefore, isavailable to be bound to the mineral. Intracellular glycoprotein canalso be made accessible for binding to the mineral by rupture of themicroorganisms after glycoprotein production.

[0034] Microorganisms that produce a glycoprotein matrix include, butare not limited to, yeast and some bacteria. A preferred yeast isSaccharomyces cervisiae. Bacteria that produce glycoprotein includebacteria within the genus Lactobacillus. For example, such bacteriainclude, but are not limited to, Lactobacillus acidophillus,Lactobacillus bulgaricus, Lactobacillus caucasicus, and Bacteriumbifidus. Preferred bacteria include Lactobacillus acidophillus, andBacterium bifidus.

[0035] Combinations of microorganisms can be used provided that at leastone of the microorganisms produces glycoprotein. When using combinationsof microorganisms, the growth of one type of microorganism should notprevent the growth of the other. For example, various types of differentyeast that produce glycoprotein can be used. Also, yeast and bacteriacan be combined to produce glycoprotein. This combination isparticularly advantageous because various types of bacteria, such asLactobacillus acidophillus, also produce glycoprotein.

[0036] Stabilizers and Additives

[0037] The composition of the invention can also include stabilizersand/or additives. Stabilizers and additives can include, for example,pharmaceutically acceptable buffers, excipients, diluents, surfactants,adjuvants, flavorings, and the like. The amounts of such additives canbe determined by one skilled in the art.

[0038] Additives can also include, for example, natural sources of theactive ingredient to be administered. Other additives can be addedwhich, for example, improve the viability of the microorganisms thatproduce the glycoprotein or increase the yield of glycoprotein thatbecomes bound to the active ingredient. For example, salts can be addedin order to increase the viability of the microorganism. Such saltsinclude, but are not limited to, calcium carbonate, ammonium sulfate,and magnesium sulfate. Calcium carbonate is preferred. The amount ofsalt added to the microorganism solution should be sufficient to obtainthe desired result of improving the viability of the organism, as isknown in the art. A preferred range of salt added to the microorganismsolution is between about 25 to about 150 grams of salt per 375 grams ofmicroorganism, such as Saccharomyces cervisiae. Approximately 40 g ofsalt per 375 gram of microorganism is most preferred.

[0039] The composition of the invention can be manufactured so as to bebiocompatible. Since the mineral is to be ingested, the microorganismused to produce the glycoprotein matrix should be suitable forconsumption by mammals, especially humans. Examples of suchmicroorganisms include Lactobacillus acidophillus and Saccharomycescervisiae. The mineral can also include pharmaceutically acceptablebuffers, excipients, diluents, adjuvants, flavorings, and the like.

[0040] Minerals

[0041] The compositions of the present invention also include a mineral.A mineral suitable for a composition of the present invention can be anymineral that is beneficial to a host. Preferred minerals are those thataid in controlling dietary starch absorption and/or carbohydratecravings, such as, for example, vanadium and chromium.

[0042] Vanadium is an ultratrace element that is a potent nonselectiveinhibitor of protein tyrosine phosphatases. Vanadium has been shown tomimic many of the metabolic actions of insulin both in vivo and invitro. For the purposes of this invention, vanadium may be naturallyoccurring, semisynthetic or synthetic. Preferably, the vanadium is boundby a glycoprotein matrix to form a complex.

[0043] Chromium is an essential trace element that has been shown toimprove the efficiency of insulin and control dietary starch absorptionand carbohydrate cravings. For the purposes of this invention, chromiumcan be naturally occurring, semisynthetic or synthetic. Preferably, thechromium is bound by a glycoprotein matrix to form a complex.

[0044] Phaseolamin

[0045] Phaseolamin is derived from Phaseolus vulgaris, or the whitekidney bean. The primary function of phaseolamin is to cause temporary,safe, side-effect free malabsorption of dietary starch. Not being boundby theory, it is believed that phaseolamin binds and neutralizesalpha-amylase. By neutralizing alpha-amylase, absorption of thecarbohydrate is inhibited. As will be discussed below, phaseolamin iseffective for inducing weight loss,

[0046] Alpha-amylase is a naturally occurring starch enzyme that isresponsible for the breakdown of starches. For example, in humans,dietary starches must be broken down into smaller components, forexample, glucose, in order to be utilized by the body.

[0047] Therefore, by neutralizing the body's enzyme that breaks downstarches into usable components, the body is unable to use thosestarches and ultimately excretes them. In addition, starches that arenot broken down into smaller components, such as glucose, do not triggerthe production of insulin.

[0048] Amylase is a digestive tract enzyme that breaks down starch intosmall units capable of being further degraded into glucose which is usedas fuel for normal metabolism and body homeostasis. Clinical use ofinhibitors of amylase has widespread appeal because a reduction ofstarch digestion will influence carbohydrate uptake in individuals inneed thereof.

[0049] Not being bound by theory, it is believed that in a compositionof the present invention, the phaseolamin acts synergistically with boththe vanadium and chromium glycoprotein complexes to enhance the effectsof the phaseolamin, vanadium and chromium.

[0050] Insulin is a hormone naturally produced by the body that is keyto controlling blood glucose levels. Circulating blood caries glucosethat provides fuel for the cells. Getting glucose into the cellsrequires insulin, which is produced in the pancreas by beta cells.Normally, the pancreas produces just enough insulin to handle the body'sneeds. This is not the case with diabetics, as will be discussed below.

[0051] Carbohydrate consumption causes an abnormal rise in insulin.Excess insulin triggers hunger and cravings, creating a vicious cycle.One way to end the cycle is to reduce or eliminate the intake ofcarbohydrates. This approach has had very little or no success ininducing weight loss for the long term. It is also extremely difficultfor individuals with impairment of glucose utilization, such as diabetesmellitus, to restrict their intake of carbohydrates.

[0052] The compositions of the present invention induce weight loss byinhibiting the absorption of carbohydrate. In addition, the compositionscontrol cravings associated with carbohydrate absorption. By inhibitingabsorption if dietary starch and controlling cravings associated withcarbohydrate absorption, the compositions of the present invention areeffective in inducing weight loss.

[0053] In addition, the compositions of the invention reduce the amountof insulin required by an individual suffering from diabetes mellitus.Accordingly, as will be discussed below, phaseolamin is an effective andbeneficial treatment for overweight, obese and/or morbidly obeseindividuals and for individuals suffering from diabetes mellitus.

[0054] Dietary Starch

[0055] Dietary starch is any consumable starch and is a mixture ofglucans (polymers of glucose). Some examples of dietary starch sourcesinclude pasta, rice, grains, potatoes and cereals. In accordance withthe present invention, dietary starch is composed of, for example,amylose and/or amylopectin.

[0056] Amylose is an essentially unbranched polymer of α-glucoseresidues which are joined by 1-4 glycosidic linkages. There can be about1000 glucose residues per amylose molecule. Amylose forms a helical coilstructure and is only slightly soluble in water due to the internal —OHgroups. Amylopectin is a highly branched polymer of α-glucose residues.Amylopectin usually consists of about 20-25 glucose residues.

[0057] Other types of dietary starch include, for example, cellulose,pectin, hydrocolloids or gums and maltodextrins. Consumption of dietarystarch has been linked to weight gain, diabetes mellitus, and variousgastrointestinal conditions including, for example, irritable bowelsyndrome.

[0058] Dosage and Administration

[0059] The glycoprotein matrix compositions containing a mineral can beadministered topically or systemically. Systemic administration can beenteral or parenteral. Enteral administration is preferred. For example,the compositions can easily be administered orally. Liquid or solid(e.g., tablets, gelatin capsules) formulations can be employed. Theformulation can include pharmaceutically acceptable excipients,adjuvants, diluents, or carriers.

[0060] The compositions can be administered in chewable tabletgranulations, with or without sugar, in powdered drink mixes, chewinggum and baking products. In a preferred embodiment, because thecompositions are stable under baking temperatures, the compositions areeffectively administered in baking mixes such as pancakes, waffles,breads, biscuits or cookies.

[0061] In accordance with the present invention, an effective amount ofa claimed composition is any amount known to those skilled in the art.Preferably, an effective amount is administered to a host just prior to,during or shortly after consuming a starch-rich meal.

[0062] Host

[0063] In a preferred embodiment the host is a mammal. Mammals include,for example, humans, as well as pet animals such as dogs and cats,laboratory animals such as rats and mice, and farm animals such ashorses and cows. Humans are most preferred.

[0064] A host in need of weight loss is, for example, any host where theweight of the host is not beneficial for its health. Another example ofa host in need of weight loss is, for example, a host that is unhappywith it's appearance due to excess weight. Some examples of hosts inneed of weight loss include, but are not limited to, hosts that sufferfrom diabetes mellitus and overweight individuals.

[0065] A host is considered overweight when the body weight of themammal is greater than the ideal body weight according to the height andbody frame of the host. The ideal body weight of a host is known tothose skilled in the art. A host is considered in need of weight loss ifits body weight is at least about 10%, preferably at least about 30%,more preferably at least about 60%, and most preferably at least about100% greater than their ideal body weight.

[0066] A host, for example, a human, is considered obese when its bodyweight is increased beyond the limitation of skeletal and physicalrequirement as the result of excessive accumulation of fat in the body.Obesity can be the result of many different forces, such as, forexample, overeating or a medical condition. A medical condition thatcould result in obesity is, for example, a low metabolic rate.

[0067] Morbid obesity occurs when an individuals weight is two, three orfour times the ideal weight for that individual, and is so-calledbecause it is associated with many seriously life-threatening disorders.

[0068] Many different approaches have been advanced for the treatment ofoverweight, obese and/or morbidly obese individuals with little successand great side-effects. The present invention provides a novelresolution which will effectively aid in inducing weight loss. Theclaimed composition comprising phaseolamin and a mineral bound by aglycoprotein matrix is effective in blocking starch absorption andcontrolling carbohydrate cravings.

[0069] The claimed composition comprising phaseolamin and a mineral,such as vanadium or chromium or both, bound by a glycoprotein matrixwill provide inhibition the absorption of starch and controlcarbohydrate cravings

[0070] The composition of the invention may also be used in a mammalsuffering from an impairment of glucose utilization, for example,diabetes mellitus. The impairment in glucose utilization may occur as aresult of a deficiency in the production of insulin by the pancreas, orby ineffectiveness of the insulin produced to utilize glucose. Asdiscussed above, insulin is necessary to the transport of glucose fromthe blood into cells.

[0071] In diabetes mellitus, insulin is either absent, in short supplyor unable to perform its job efficiently. If glucose cannot get into thecells, it accumulates in the blood creating increased blood glucose.

[0072] All clinicians recognize that dietary factors play a role in thetreatment of diabetes mellitus. In many diabetic individuals, weightloss may cure or significantly improve diabetes mellitus.

[0073] A number of meal planning systems are used in conventionaldiabetes care settings. One of the most popular systems is carbohydratecounting which involves maintaining a relatively constant level ofcarbohydrates from day to day. By doing so, the insulin needs of thediabetic individual are more or less predictable and constant.

[0074] Individuals suffering from diabetes mellitus usually need toingest insulin to aid in the absorption of blood glucose into cells.Often, after consuming a carbohydrate rich meal, a diabetic's insulinrequirements may markedly increase to deal with the high blood glucoselevels.

[0075] Accordingly, by inhibiting the absorption of dietary starch, acomposition of the present invention will effectively decrease theinsulin requirements of a diabetic host.

[0076] The following examples are provided to assist in a furtherunderstanding of the invention. The particular materials and conditionsemployed are intended to be further illustrative of the invention andare not limiting upon the reasonable scope thereof.

EXAMPLE 1 Preparation of Mineral+Glycoprotein Matrix (GPM) Complex

[0077] This example demonstrates the preparation of a mineral (i.e.,chromium or vanadium) plus glycoprotein matrix (GPM) complex to yield amineral+GPM complex. The method employs preparing, in a first container,an aqueous solution of USP inorganic mineral salt and adding a peptonemade of amino acids.

[0078] In a second container an active yeast solution is prepared.Active baker's yeast, Saccharomyces cervisiae is added to water to forman aqueous solution. Maltose and gum acacia are then added.

[0079] The first container containing the mineral is then inoculatedvery slowly into the active yeast solution to form a live fermentedsolution. The mixture is allowed to ferment for four to six hours. Topromote yeast growth, plant proteins and carbohydrates are added.Proteolytic enzyme, such as papain, is then added.

[0080]Lactobacillus acidophillus is added to the live fermented solutionand allowed to ferment for about 2 hours. Active fermentation is thenstopped by heating the solution to 160-170° F. for three hours.

[0081] The fermented mineral solution is then homogenized in a shearingpump (Charles Ross & Sons Corp.) for approximately 1-2 hours and spraydried (NIRO, Nicholas Engineers Research Corp.) for approximately 4hours. The resulting product is a powder containing the mineral GPMcomplex.

EXAMPLE 2 Preparation of Phaseolamin

[0082] Whole dried non-genetically modified organism (GMO) Phaseolusvulgaris beans were inspected for cleanliness. Upon quality controlapproval of the beans, the dried beans were milled and placed in asolvent, preferably water, or an alcohol-water mixture.

[0083] Phaseolamin was extracted from the bean fraction multiple timesunder strict standard operating procedures as are known to those in theart, such as, for example, affinity chromatography. The extractedphaseolamin was then spray dried and tested for bacterial contamination,mesh (i.e., particle size), moisture content, potency, and organoleptics(i.e., physical characteristics, such as, color, taste, odor, powder,and liquid).

EXAMPLE 3 Preparation of Phaseolamin with Mineral+GPM Complex

[0084] Phaseolamin was added to a mineral+GPM complex (obtained fromExample 1) and mixed together. The resulting mixture yielded acomposition comprising phaseolamin and a mineral+GPM complex. Thismethod may be used to prepare, for example, 1) phaseolamin withchromium+GPM complex; 2) phaseolamin with vanadium+GPM complex; and 3)phaseolamin with chromium+GPM complex and vanadium+GPM complex. Themethods for preparing the above listed compositions are brieflydescribed below.

[0085] Briefly, to prepare phaseolamin with a chromiun+GPM complex, 4500mgs of phaseolamin was added to 3 mgs of chromium+GPM complex and mixedtogether. The resulting mixture yielded 6 μgs of elemental chromium per4.5 g of phaseolamin.

[0086] To prepare phaseolamin with a vanadium+GPM complex, phaseolaminat 4500 mgs was added to 3 mgs of vanadium+GPM complex and mixedtogether. The resulting mixture yielded 6 μg of elemental vanadium per4.5 g of phaseolamin.

[0087] To prepare phaseolamin with chromium+GPM complex and vanadium+GPMcomplex, 4500 mgs of phaseolamin at was added to 1.5 mgs of chromium+GPMcomplex and 1.5 mgs of vanadium+GPM complex and mixed together. Theresulting mixture yielded 3 μg of elemental chromium and 3 μg ofelemental vanadium per 4.5 g of phaseolamin.

EXAMPLE 4 Efficacy of Phaseolamin

[0088] To study the efficacy of phaseolamin, five males and five females(ages 21 to 57) participated in a double-blind placebo-controlledcrossover study. All subjects were instructed to go about their usualdaily routines throughout the study. After an overnight fast, theparticipants were sampled for blood and then given in a random mannereither:

[0089] Group 1) placebo) a starch meal consisting of 4 slices of whitebread (60 grams of carbohydrate) with 42 grams of soybean oil margarineand 4 grams of Sweet N' Low spread on the bread; or

[0090] Group 2) a starch meal consisting of 4 slices of white bread (60grams of carbohydrate) with 42 grams of soybean oil margarine and 4grams of Sweet N' Low spread on the bread; plus 1.5 grams of Phaseolamin2250™ (Pharmachem Laboratories).

[0091] Plasma glucose was measured by a commercial enzyme kit (SigmaChemical Company) from blood drawn at baseline, and every 30 minutes for4 hours. After one week the regimen was repeated where the starch mealcontaining Phaseolamin 2250™ was administered to the subjects group 1and the subjects in group 2 were administered the starch meal withoutPhaseolamin 2250™.

[0092] The subjects were normoglycemic as measured by fasting glucoseconcentration which averaged 98 mg/dl for the placebo and 104 for thePhaseolamin 2250™ starch meal. From 60 to 120 minutes after consumptionof the starch meal, the change in plasma glucose of the Phaseolamin2250™ group from the baseline was ½ to ⅓ of the level of the placebogroup (FIG. 1). Phaseolamin 2250™ consumption caused the plasma glucoseto return to baseline values 20 minutes earlier than the placebo withoutPhaseolamin 2500™.

[0093] The average area under the plasma glucose time curve from 0 to150 minutes, which is a measure of absorption and metabolism, was 57%lower with Phaseolamin 2250™. Plotting the average change in glucoseconcentration from 30 minutes to 210 minutes, the area under the curvewas positive for the placebo but negative for Phaseolamin 2250™.

[0094] This indicates that very little of the glucose from the starch inthe bread was absorbed when co-ingested with Phaseolamin 2250™ and thatthe glucose was cleared very rapidly. No side effects were observed insubjects treated with Phaseolamin 2250™.

We claim:
 1. A composition comprising phaseolamin and a mineral, whereinsaid mineral is bound by a glycoprotein matrix.
 2. A compositionaccording to claim 1, further comprising microorganisms.
 3. Acomposition according to claim 2, wherein said microorganisms producesaid glycoprotein matrix.
 4. A composition according to claim 2, whereinsaid microorganisms include yeast.
 5. A composition according to claim4, wherein said yeast includes Saccharomyces cervisiae.
 6. A compositionaccording to claim 2, wherein said microorganisms include bacteria.
 7. Acomposition according to claim 6, wherein said bacteria includesLactobacillus.
 8. A composition according to claim 6, wherein saidbacteria includes Lactobacillus acidophillus or Bacterium bifidus.
 9. Acomposition according to claim 2, wherein said microorganisms includeyeast and bacteria.
 10. A composition according to claim 1, furthercomprising stabilizers and/or additives.
 11. A composition according toclaim 1, wherein said composition is added to a baking mix.
 12. Acomposition according to claim 11, wherein said baking mix is selectedfrom the group consisting of pancake, waffle, bread, biscuit and cookiemix.
 13. A composition according to claim 1, wherein said mineral isvanadium or chromium or both.
 14. A method for inhibiting absorption ofdietary starch in a host, said method comprising administering to saidhost, an effective amount of a composition comprising phaseolamin and amineral, wherein said mineral is bound by a glycoprotein matrix.
 15. Amethod according to claim 14, wherein said composition further comprisesmicroorganisms.
 16. A method according to claim 15 wherein saidmicroorganisms produce said glycoprotein matrix.
 17. A method accordingto claim 15, wherein said microorganisms include yeast.
 18. A methodaccording to claim 17, wherein said yeast includes Saccharomycescervisiae.
 19. A method according to claim 15, wherein saidmicroorganisms include bacteria.
 20. A method according to claim 19,wherein said bacteria includes Lactobacillus.
 21. A method according toclaim 19, wherein said bacteria includes Lactobacillus acidophillus orBacterium bifidus.
 22. A method according to claim 15, wherein saidmicroorganisms include yeast and bacteria.
 23. A method according toclaim 14, further comprising stabilizers and/or additives.
 24. A methodaccording to claim 14, wherein said dietary starch is amylose.
 25. Amethod according to claim 14, wherein said host is a human.
 26. A methodaccording to claim 25, wherein said human is obese.
 27. A methodaccording to claim 25, wherein said human is morbidly obese.
 28. Amethod according to claim 25, wherein said human suffers from animpairment of glucose utilization.
 29. A method according to claim 28,wherein said impairment of glucose utilization is diabetes mellitus. 30.A method according to claim 14, wherein said composition is administeredin a baked good.
 31. A method according to claim 30, wherein said bakedgood is selected from the group consisting of pancake, waffle, bread,biscuit and cookie.
 32. A method according to claim 14, wherein saidmineral is vanadium or chromium or both.
 33. A method for inducingweight loss in a host in need thereof, said method comprisingadministering an effective amount of a composition comprisingphaseolamin and a mineral, wherein said mineral is bound by aglycoprotein matrix.
 34. A method according to claim 33, wherein saidcomposition further comprises microorganisms.
 35. A method according toclaim 34, wherein said microorganisms produce said glycoprotein matrix.36. A method according to claim 34, wherein said microorganisms includeyeast.
 37. A method according to claim 36, wherein said yeast includesSaccharomyces cervisiae.
 38. A method according to claim 34, whereinsaid microorganisms include bacteria.
 39. A method according to claim38, wherein said bacteria includes Lactobacillus.
 40. A method accordingto claim 38, wherein said bacteria includes Lactobacillus acidophillusor Bacterium bifidus.
 41. A method according to claim 34, wherein saidmicroorganisms include yeast and bacteria.
 42. A method according toclaim 33, further comprising stabilizers and/or additives.
 43. A methodaccording to claim 33, wherein said host is a human.
 44. A methodaccording to claim 43, wherein said human is obese.
 45. A methodaccording to claim 43, wherein said human is morbidly obese.
 46. Amethod according to claim 43, wherein said human suffers an impairmentof glucose utilization.
 47. A method according to claim 46, wherein saidimpairment of glucose utilization is diabetes mellitus.
 48. A methodaccording to claim 33, wherein said composition is administered in abaked good.
 49. A method according to claim 48, wherein said baked goodis selected from the group consisting of pancake, waffle, bread, biscuitand cookie.
 50. A method according to claim 33, wherein said mineral isvanadium or chromium or both.
 51. A method for controlling carbohydratecravings in a host in need thereof, said method comprising administeringto said host an effective amount of a composition comprising phaseolaminand a mineral, wherein said mineral is bound by a glycoprotein matrix.52. A method according to claim 51, wherein said composition furthercomprises microorganisms.
 53. A method according to claim 52, whereinsaid microorganisms produce said glycoprotein matrix.
 54. A methodaccording to claim 52, wherein said microorganisms include yeast.
 55. Amethod according to claim 54, wherein said yeast includes Saccharomycescervisiae.
 56. A method according to claim 52, wherein saidmicroorganisms include bacteria.
 57. A method according to claim 56,wherein said bacteria includes Lactobacillus.
 58. A method according toclaim 56, wherein said bacteria includes Lactobacillus acidophillus orBacterium bifidus.
 59. A method according to claim 52 wherein saidmicroorganisms include yeast and bacteria.
 60. A method according toclaim 51, further comprising stabilizers and/or additives.
 61. A methodaccording to claim 51, wherein said host is a human.
 62. A methodaccording to claim 61, wherein said human is obese.
 63. A methodaccording to claim 61, wherein said human is morbidly obese.
 64. Amethod according to claim 61, wherein said human suffers from animpairment of glucose utilization.
 65. A method according to claim 64,wherein said impairment of glucose utilization is diabetes mellitus. 66.A method according to claim 51, wherein said composition is administeredin a baked good.
 67. A method according to claim 66, wherein said bakedgood is selected from the group consisting of pancake, waffle, bread,biscuit and cookie.
 68. A method according to claim 51, wherein saidmineral is vanadium or chromium or both.
 69. A method for decreasinginsulin requirements in a diabetic host, said method comprisingadministering an effective amount of a composition comprisingphaseolamin and a mineral, wherein said mineral is bound by aglycoprotein matrix.
 70. A method according to claim 69, wherein saidcomposition further comprises microorganisms.
 71. A method according toclaim 70, wherein said microorganisms produce said glycoprotein matrix.72. A method according to claim 70, wherein said microorganisms includeyeast.
 73. A method according to claim 72, wherein said yeast includesSaccharomyces cervisiae.
 74. A method according to claim 70, whereinsaid microorganisms include bacteria.
 75. A method according to claim74, wherein said bacteria includes Lactobacillus.
 76. A method accordingto claim 74, wherein said bacteria includes Lactobacillus acidophillusor Bacterium bifidus.
 77. A method according to claim 70, wherein saidmicroorganisms include yeast and bacteria.
 78. A method according toclaim 69, further comprising stabilizers and/or additives.
 79. A methodaccording to claim 69, wherein said host is a human.
 80. A methodaccording to claim 69, wherein said composition is administered in abaked good.
 81. A method according to claim 80, wherein said baked goodis selected from the group consisting of pancake, waffle, bread, biscuitand cookie.
 82. A method according to claim 69, wherein said mineral isvanadium or chromium or both.